When it comes to medical issues, countries try to leave no stone unturned because any form of negligence will result in loss of lives for the wrong reasons, and South Africa is not left out in this regard. Before opening a company where you sell drugs, medical devices, perform clinical trials, or do anything health-related, you have to apply for a SAHPRA license and get approved.
Applying for this license requires that you follow some set of procedures and make some payments. Getting a SAHPRA license is very important because it makes your company eligible to deal on medical-related products, and your company name will also be published in their list of licensed establishments.
What You Should Know About SAHPRA License
SAHPRA, which is an acronym for South African Health Product Regulatory Authority, is a subsidiary of the National Department of Health. It was created by the South African government to monitor and investigate all health-related products to ensure their safety, quality, and efficacy.
Part of the duties and responsibilities of the SAHPRA is to issue licenses to establishments to import, manufacture, sell, and distribute any health-related product across the country. Before you are given this license, depending on the type of product and establishment you intend to run, you must meet basic requirements and standards to ensure that your product will not cause health hazards to the people who use it.
When you register your establishment with SAHPRA, and it is licensed to sell health-related products, SAHPRA will add its name to the list of licensed establishments. The category of establishments you will be published under will depend on the kind of product you manufacture, import, export or, sell within the country.
What Type Of License Can I Get From SAHPRA?
The kind of SAHPRA license you apply for will depend on the product your establishment deals with. These different types of licenses have general requirements but still have some unique requirements as well. Here is a list of all the license applications you can send to SAHPRA:
- Cannabis Cultivation Licence: This license is issued to establishments that deal in the cultivation, importation, or manufacture of cannabis for medical purposes. To obtain this license, you must have good manufacturing and agricultural practices.
- Wholesalers of Medicine & Scheduled Substances (APIs): This license is based on the provisions of the Medicines and Related Substances Act, 1965, Section 22C and 22D, and with Regulation 19. It is issued to individuals and establishments who want to act as wholesalers or distributors of medicine. To obtain this license, you must have a good wholesaling practice.
- GMP/Pharma Establishment Licence (Manufactures, Importers & Exporters): This license is issued to establishments that manufacture, import, or export medicines. Because of how important it is for details to be given to the manufacturing practice these establishments work with, one of the major perquisites to getting this license is good manufacturing practice. Hence, you must submit evidence of your Good manufacturing practice. You can collect a guideline for what SAHPRA refers to as a good manufacturing practice from the office of the Chief Executive Officer, [email protected].
You can only submit application forms for the different types of the license above and GMP & CPP certificates to SAHPRA. If you submit any other type of application, your entry will be deleted, and your email will be blocked from sending anything to SAHPRA. For each of these license applications, you will be required to prepare and submit a ‘site master file.’
How Do I Apply For a SAHPRA License?
Although most of the SAHPRA license application forms are long and will take some time to fill, the general application process is not difficult. To avoid moving in circles, you must follow the appropriate procedures, which include the following:
- Visit the SAHPRA Licence application Page.
- Click on the license you want to apply for to download the application form.
- Carefully fill the form in black ink (any other color must be initialed and dated. Applications filled with white ink will be rejected).
- Proceed to make payments.
- Submit the application form to [email protected].
The SAHPRA license application form is to be submitted alongside the following documents:
- License application cover letter.
- Product list with a POP of annual retention fee for each product from the date the product was registered.
- SAPC certificate or SAPC Case Number of recording of a pharmacy owner.
- NDOH premises license or a copy of a completely filled application form.
- Copy of POP of the license annual retention fee for all preceding years (if the license is older than a year).
- Registration or SAPC case number of a responsible Pharmacist.
- Proof of business ownership (CIPC/CIPRO/DTI certificate).
- Proof of payment with the correct reference (Annexure A).
- Newest Latest Inspection resolution (where applicable).
- If you are applying for license renewal, then attach your previous license.
Please note that your entire application is expected to be in a zip file.
How Much Does The License Application Cost?
The cost of applying for a SAHPRA license differs, depending on the kind of establishment. Here is a detailed list of the application fee for each establishment:
- Manufacturing: R25,200
- Wholesale: R15,000
- Distribution: R15,000 (Holder of Certificate of Registration – HCR)
- Import: 15,000 (HCR)
- Export: 15,000 (HCR)
You can make payments using this bank details:
- Account Name: SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY
- Special Name: The Medicines Control Council
- Account Type: Cheque/Current Account
- Account Number: 40-5939-2080
- Bank: ABSA
- Bank Branch Code: 632005
- Bank Physical Address: 240 VERMEULEN STREET, PRETORIA, 0001, SOUTH AFRICA
- Swift Code: ABSAZAJJ
Before making payments for a SAHPRA license application, it is advised that you go through the SAHPRA Fee Categorisation Guideline, Applicants Cover Page, and Gazette Fee Schedule. These documents can be found on the official SAHPRA website. Here are the basic rules to adhere to when making payments:
- Payments are to be referenced in accordance with the SAHPRA Fee Categorisation Guideline (Annexure A).
- If the bank payment slip has limited space for referencing, then forfeit the dashes (/) and spacing.
- All payments must be made indirectly into the SAHPRA account electronically or via manual deposits.
- Cheque payments are not allowed.
- Don’t pay for more than one service at a time.
- You can make payments before application, and required dossiers are ready for submission.
- Invoice queries can be requested via [email protected].
- Once the payment is made, send the following documents to [email protected]. Failure to do this within 12 months means that your payment will be forfeited.
- Proof of Payment (with SAHPRA References in Categorisation Guideline) from applicants’ bank account.
- Applicant’s cover letter.
- After payment has been made, you will be notified within 14 working days to submit your application.
- You can apply for a submission date extension within the 14 working days window.
From the day you submit your application, it takes 5 working days for your license to be approved and ready.
How Do I Contact SAHPRA?
If you wish to make further inquiries about the SAHPRA license application, you can send a mail to [email protected], and if you have an emergency, you should send your mail to [email protected], or you can also reach SAHPRA customer care by calling 012 501 0300.
You can also visit the SAHPRA head office located at Building A Loftus Park 402 Kirkness Street Arcadia Pretoria. This way, you can make your inquiries in person and get personal assistance. Alternatively, you can send your request through the post office to South African Health Products Regulatory Authority, Private Bag X828 Pretoria 0001.
For media inquires, you can send a mail to [email protected] or call 066 120 2669 or 012 501 0422 using your cellphone. Alternatively, you can visit the SAHPRA media inquiry page to drop your message online.